A double-blind randomised controlled study to evaluate the effectiveness of a fermented red ginseng extract supplement (FermenGIN) compared to placebo on blood circulation parameters in an adult population.

Exclusion Criteria28

• Unstable or serious illness (e.g. kidney, liver, GIT, heart conditions, diabetes, thyroid gland function, malignancy)
• Malignancy or treatment for malignancy within the previous 2 years [this excludes non-melanoma (e.g. BCC and SCC) skin cancers not requiring radiation or chemotherapy]
• Receiving / prescribed coumadin (Warfarin), heparin, dalteparin, enoxaparin or other anticoagulation therapy or substrates of P-glycoprotein including (but not limited to) calcium channel blockers, cyclosporin, digoxin, erythromycin and protease inhibitors.
• Use of other dietary supplements for circulation (e.g. fatty acids, CoQ10, L-arginine) or medications (e.g. Pentoxifylline and vasodilators like nitroglycerin) of a stable dose for less than 3 months
• Active smokers, nicotine, alcohol abuse (>14 alcoholic drinks week), drug abuse
• Allergic to any of the ingredients in active or placebo formula
• People suffering any neurological disorders such as MS
• Any condition which in the opinion of the investigator makes the participant unsuitable for inclusion
• Pregnant or lactating women
• Females of child bearing potential not using a highly effective form of contraception (b,c)(i.e. methods which result in low failure rate, i.e. less than 1% per year, when used consistently and correctly like the oral contraception pill, birth control implant e.g. implanon)
• Those with a history of myocardial infarction, angina or bleeding disorders
• People who have uncontrolled hypertension (systolic blood pressure > 160 mmHg or diastolic blood pressure > 100 mmHg) or diabetes mellitus (fasting glucose > 180mg/dl, or intake of hypoglycemic agents within 3 months prior to screening)
• Those who have uncontrolled thyroid diseases
• Those who consumed product that may affect the study within 2 weeks (e.g. red ginseng, ginseng, Natto, etc)
• Participants in another trial or had been in any other trial during last 30 days
• Those who have abnormal weight (BMI>35-<18.5 kg/m2)
• a) A blood test will be performed when the participant has provided written consent following the PICF and study requirements having been read and explained to them. The signing of the consent form at this stage does not guarantee enrolment into the study.
• b) Examples of acceptable forms of highly effective contraception include:
• Established use of oral, injected or implanted hormonal methods of contraception.
• Placement of an intrauterine device (IUD) or intrauterine system (IUS).
• Sterilised male partner (with the appropriate post-vasectomy documentation of the absence of sperm in the ejaculate).
• True abstinence: When this is in line with your preferred and usual lifestyle
• c) Examples of non-acceptable methods of contraception include:
• Condoms alone or double barrier
• Periodic abstinence (e.g. calendar, ovulation, symptothermal, post ovulation)
• Withdrawal
• Spermicide (as it is not approved as a method of contraception in Australia)
• It is the responsibility of the participant to ensure that prior to and during the trial, that if they intend to try to conceive, change birth control or if there is any chance they suspect they are pregnant, they notify the trial investigators immediately.